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The Human Medicines (Amendment) (No. 2) Regulations 2014
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- Northern Ireland Statutory Rules
- 2014 No. 324
- Regulation 17
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Substitution of regulation 97
17. For regulation 97 (breach of pharmacovigilance condition) substitute—
“Breach of pharmacovigilance condition
97.—(1) The holder of a marketing authorisation or a parallel import licence is guilty of an offence if the holder fails to comply with a condition to which the marketing authorisation or parallel import licence is subject by virtue of regulation 59 (conditions of a UK marketing authorisation or parallel import licence: general).
(2) The holder of a marketing authorisation is guilty of an offence if the holder fails to comply with a condition to which the marketing authorisation is subject by virtue of regulation 60 (conditions of a UK marketing authorisation: exceptional circumstances) or 61 (conditions of a UK marketing authorisation: new obligations post-authorisation).”
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